MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-DR DANIELSON AC PACK

Catalog Number	DYNJ51038R
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bullet tip punch on aortic punch locks up inside the device, comes in medline pack.
Additional Manufacturer Narrative
The account reported the bullet tip punch on aortic punch locks up inside the device, and the facility reported the product "would no release and remain stuck in that position" when engaged to create the opening.A sample was received, the account returned an aortic punch for the investigation, no other parts of the pack were returned, initial inspection found no visual defects, finished good production records and pack build were reviewed with no issues noted, and dimensional analysis was completed on all punch components with the dimensions within specification.When testing for functionality, the tip would lock up inside the device, confirming the defect; based on the complaint details, the root cause is considered to be a vendor product issue relating to the component manufacturing process.The complaint was provided to the vendor for further evaluation, and the supplier quality team will monitor this issue for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-DR DANIELSON AC PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: juan mota ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50531279
• Report Number: 1417592-2026-28895
• Device Sequence Number: 18608276
• Product Code: OEZ
• UDI-Device Identifier: 40195327298259
• UDI-Public: 40195327298259
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJ51038R
• Device Lot Number: 23HBD834
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown